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EC number: 227-022-5 | CAS number: 5601-29-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin irritation: Not irritant
Eye irritation: Irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August 08, 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test comparable to guideline study with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetica" (1959) of the US Association of Food and Drug Officials'(AFDO)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.8 to 2.3 kg
- Housing: housed singly in metal cages (overall dimensions 47x32x34 cm)
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 (3 male and 3 female)
- Details on study design:
- 6 rabbits were shaved one day before treatment with an electric clipper-on the flanks .
The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied imdiately to the prepared skin. The patch was covered wíth an-impermeable foil of 5x5 cm, which was fixed to the body of the animal with adhesive tape.
The test substance was applied to each side in quantities of 0.5 g . Before application the test materiel was wetted with tap water.
The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 7 days. - Irritation parameter:
- erythema score
- Basis:
- animal: 426, 428, 430, 439, 441, 443
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no symptoms
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 426, 428, 430, 439, 441, 443
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no symptoms
- Remarks on result:
- other: intact skin
- Interpretation of results:
- other: Not classified
- Remarks:
- According to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Non irritant
- Executive summary:
Method
The skin irritation was determined in an irritation test on rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO)", similar to OECD guideline 404.
6 rabbits were shaved one day before treatment with an electric clipper-on the flanks . The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied imdiately to the prepared skin. The patch was covered wíth an-impermeable foil of 5x5 cm, which was fixed to the body of the animal with adhesive tape. The test substance was applied to each side in quantities of 0.5 g . Before application the test materiel was wetted with tap water. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 7 days.
Conclusion
Not irritant
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August 08, 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test comparable to guideline study with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2.3 kg
- Housing: kept separately in metal cages (overall dimensions 47x32x34cm)
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 1 minute
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 (3 male and 3 female)
- Details on study design:
- Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with
physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days. - Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal: 488
- Time point:
- other: mean value following grading at 24, 48 and 72 hours
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal: 490, 497
- Time point:
- other: mean value following grading at 24, 48 and 72 hours
- Score:
- ca. 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: 488
- Time point:
- other: mean value following grading at 24, 48 and 72 hours
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: 490, 497
- Time point:
- other: mean value following grading at 24, 48 and 72 hours
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 488
- Time point:
- other: mean value following grading at 24, 48 and 72 hours
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 490
- Time point:
- other: mean value following grading at 24, 48 and 72
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 497
- Time point:
- other: mean value following grading at 24, 48 and 72
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 488, 497
- Time point:
- other: mean value following grading at 24, 48 and 72
- Score:
- ca. 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 490
- Time point:
- other: mean value following grading at 24, 48 and 72
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: washed eyes
- Interpretation of results:
- other: Irritating
- Remarks:
- According to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Irritant
- Executive summary:
Method:
The eye irritation was determined in an irritation test on rabbits according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 405.
0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with
physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days.
Result:
Irritant
Reference
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin Irritation
According to the CLP Regulation (EC n. 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
A substance has to be classified as Category 1 (Corrosive) if there is the production of irreversible damage to the skin in more than 1 of three animals.
A substance has to be classified as Category 2 (Irritant) if shows:
(1) Mean value of ≥ 2.3 - ≤ 4.0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Under the test condition no signs of irritation were observed therefore the test substance has not need to be classified.
Eye Irritation
According to the CLP Regulation (EC n. 1272/2008), Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application
Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
A substance has to be classified as Category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 3 and/or
— iritis > 1.5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
A substance has to be classified as Category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:
at least in 2 of 3 tested animals, a positive response of:
- corneal opacity ≥ 1 and/or
- iritis ≥ 1, and/or
- conjunctival redness ≥ 2 and/or
- conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
Under the test condition the tested substance is classified as Eye Irr. 2 (H319), according to the CLP Regulation.
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